Zarixa

Package leaflet: Information for the user

ZARIXA, 10 mg, hard capsules
Rivaroxaban
Please read this leaflet carefully before taking this medicine, as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm them, even if their symptoms are the same.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What ZARIXA is and what it is used for
2. Important information before taking ZARIXA
3. How to take ZARIXA
4. Possible side effects
5. How to store ZARIXA
6. Contents of the pack and other information

1. What ZARIXA is and what it is used for

ZARIXA contains the active substance rivaroxaban and is used in adults to:

• prevent the formation of blood clots in veins after hip or knee replacement surgery. Your doctor has prescribed this medicine because your risk of developing blood clots is increased after surgery,
• treat blood clots in the veins of the legs (deep vein thrombosis) and in the blood vessels of the lungs (pulmonary embolism), and to prevent the recurrence of blood clots in the blood vessels of the legs and/or lungs.

ZARIXA contains the active substance rivaroxaban and belongs to a group of medicines called anticoagulants. It works by blocking a blood clotting factor (Factor Xa), thereby reducing the tendency for blood clots to form.

2. Important information before taking ZARIXA

When not to take ZARIXA

• if the patient is allergic to rivaroxaban or any of the other ingredients of this medicine (listed in section 6),
• if the patient is experiencing excessive bleeding,
• if the patient has a disease or condition of an organ that leads to an increased risk of serious bleeding (e.g. stomach ulcer, trauma or bleeding into the brain, recent surgery on the brain or eyes),
• if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery,
• if the patient has a liver disease that leads to an increased risk of bleeding,
• if the patient is pregnant or breastfeeding.

Do not use ZARIXA and inform your doctor if you suspect any of the above-mentioned conditions.
Warnings and precautions
Talk to your doctor or pharmacist before taking ZARIXA.
When to exercise particular caution when taking ZARIXA

• if the patient has an increased risk of bleeding, such as in the following conditions:
  • moderate or severe kidney disease, as kidney function may affect the amount of medicine acting in the patient's body,
  • if the patient is taking other medicines that prevent blood clotting (e.g. warfarin, dabigatran, apixaban or heparin), except when switching anticoagulant therapy or if heparin is administered to maintain catheter patency in a vein or artery (see section "Other medicines and ZARIXA"),
  • blood clotting disorders,
  • very high blood pressure that does not decrease despite medication,
  • diseases of the stomach or intestines that may cause bleeding, e.g. inflammation of the intestines and stomach or inflammation of the oesophagus (throat and oesophagus), e.g. due to gastro-oesophageal reflux disease (backflow of stomach acid into the oesophagus), or tumours located in the stomach or intestines or in the genital or urinary system,
  • blood vessel disease in the back of the eye (retinopathy),
  • lung disease with dilated bronchi filled with pus (bronchiectasis) or previous lung bleeding,
• in patients with prosthetic heart valves,
• if the patient has a disorder called antiphospholipid syndrome (an immune system disorder causing an increased risk of blood clots), the patient should inform the doctor, who will decide whether treatment needs to be changed,
• if the patient has abnormal blood pressure or if surgery or another treatment to remove a blood clot from the lungs is planned.

If you suspect any of the above-mentioned conditions, inform your doctor before taking ZARIXA. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the patient needs to undergo surgery:

• strictly follow the doctor's instructions regarding the timing of taking ZARIXA before or after surgery,
• if during surgery a lumbar puncture or placement of a catheter into the spine is planned (e.g. for epidural or spinal anaesthesia or for pain relief):
  • strictly follow the doctor's instructions regarding the timing of taking ZARIXA,
  • immediately inform the doctor if, after the anaesthesia ends, the patient experiences symptoms such as: numbness, weakness in the lower limbs, disturbances in bowel movements or bladder function, as immediate treatment is required in such cases.

Children and adolescents
ZARIXA 10 mg capsules are not recommended for patients under 18 years of age. There is insufficient data on the use of the medicine in children and adolescents.
Other medicines and ZARIXA
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take, including those available without a prescription.

• If the patient is taking
• certain antifungal medicines (e.g. fluconazole, itraconazole, voriconazole, posaconazole), unless they are used only topically on the skin,
• ketoconazole tablets (used in the treatment of Cushing's syndrome, in which the body produces too much cortisol),
• certain antibiotics (e.g. clarithromycin, erythromycin),
• certain antiviral medicines used in HIV infection or AIDS treatment (e.g. ritonavir),
• other medicines used to reduce blood clotting (e.g. enoxaparin, clopidogrel or vitamin K antagonists such as warfarin or acenocoumarol),
• anti-inflammatory and pain-relieving medicines (e.g. naproxen or acetylsalicylic acid),
• dronedarone, a medicine used to treat heart rhythm disorders,
• certain antidepressants (selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI)).

If you suspect any of the above-mentioned conditions, inform your doctor before taking ZARIXA, as the effect of ZARIXA may be enhanced. The doctor will decide whether to use this medicine and whether the patient requires particularly close monitoring.
If the doctor considers that the patient has an increased risk of developing gastric or duodenal ulcer, he may prescribe treatment to prevent peptic disease.

• If the patient is taking
• certain medicines used to treat epilepsy (phenytoin, carbamazepine, phenobarbital),
• St John's wort ( Hypericum perforatum ), a herbal remedy used for depression,
• rifampicin, which belongs to the group of antibiotics.

If you suspect any of the above-mentioned conditions, inform your doctor before taking ZARIXA, as the effect of ZARIXA may be reduced. The doctor will decide whether to use ZARIXA and whether the patient requires particularly close monitoring.
Pregnancy and breastfeeding
Do not take ZARIXA if you are pregnant or breastfeeding. If there is a risk that you may become pregnant, you should use an effective method of contraception during treatment with ZARIXA. If you become pregnant while taking this medicine, inform your doctor immediately, who will decide on further management.
Driving and using machines
ZARIXA may cause dizziness (common side effects) and fainting (uncommon side effects) (see section 4, "Possible side effects"). Patients experiencing these side effects should not drive, ride a bicycle, or operate tools or machinery.
ZARIXA contains sodium.
The medicine contains less than 1 mmol of sodium (23 mg) per hard capsule, which essentially means it is "sodium-free".

3. How to take ZARIXA

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, you should
consult your doctor or pharmacist.
How many capsules to take

• To prevent the formation of blood clots in the veins after hip or knee replacement surgery: the recommended dose is one 10 mg ZARIXA capsule taken once daily.
• For the treatment of blood clots in the leg veins, blood clots in the blood vessels of the lungs, and to prevent recurrence of blood clots: after at least 6 months of treatment for blood clots, the recommended dose is one 10 mg capsule once daily or one 20 mg capsule once daily. Your doctor has prescribed ZARIXA 10 mg once daily for you.

The capsule should be swallowed whole, preferably with water.
ZARIXA can be taken with or without food.
If you have difficulty swallowing the entire capsule, discuss alternative ways of taking ZARIXA with your doctor.
The contents of the capsule may be mixed with water or soft food such as apple puree immediately before administration.
If necessary, your doctor may administer the contents of the ZARIXA capsule through a gastric tube.
When to take ZARIXA
You should take one capsule every day until your doctor decides to stop treatment.
It is best to take the capsule at the same time each day, as this makes it easier to remember.
Your doctor will decide how long treatment should continue.
To prevent blood clots in the leg veins after hip or knee replacement surgery:
The first capsule should be taken 6 to 10 hours after surgery.
For patients undergoing major hip surgery, treatment usually lasts 5 weeks.
For patients undergoing major knee surgery, treatment usually lasts 2 weeks.
Taking more ZARIXA than prescribed
If you have taken more ZARIXA than prescribed, contact your doctor immediately.
Taking too high a dose of ZARIXA increases the risk of bleeding.
If you forget to take ZARIXA
If you forget to take a dose, take the capsule as soon as you remember.
Take the next capsule the following day, and then continue taking the capsules as usual, once daily.
Do not take a double dose to make up for a missed dose.
Stopping ZARIXA treatment
Do not stop taking ZARIXA without first talking to your doctor, as ZARIXA helps prevent a serious condition.
If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like any medicine, ZARIXA may cause adverse effects, although not everyone will experience them.
As with other medicines with a similar mechanism of action that reduce blood clot formation, ZARIXA may cause bleeding, which could potentially be life-threatening. Excessive bleeding may lead to a sudden drop in blood pressure (shock). Signs of bleeding are not always obvious or visible.
You should contact your doctor immediately if any of the following adverse effects occur:

Signs of bleeding:

• Bleeding into the brain or inside the skull (symptoms may include headache, one-sided paralysis, vomiting, seizures, decreased level of consciousness, and neck stiffness. This is a serious medical emergency. Seek immediate medical help!),
• Prolonged or excessive bleeding,
• Unusual weakness, fatigue, paleness, dizziness, headache, unexplained swelling, shortness of breath, chest pain, or angina. Your doctor may decide that close monitoring or a change in treatment is necessary.

Signs of severe skin reactions:

• Widespread, acute skin rash, blistering, or mucosal lesions, e.g., on the tongue or eyes (Stevens-Johnson syndrome, toxic epidermal necrolysis),
• Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), characterized by rash, fever, internal organ inflammation, hematological abnormalities, and systemic involvement. The frequency of these adverse effects is very rare (occurring in up to 1 in 10,000 people).

Signs of serious allergic reactions
You should contact your doctor immediately if any of the following adverse effects occur:

• Swelling of the face, lips, mouth, tongue, or throat; hives; breathing difficulties; sudden drop in blood pressure. The frequency of severe allergic reactions is very rare (anaphylactic reactions, including anaphylactic shock, may occur in up to 1 in 10,000 people) and uncommon (angioedema and allergic edema may occur in 1 in 100 people).

General list of possible adverse effects
Common adverse effects (may occur in 1 out of 10 people)

• Decreased number of red blood cells, which may cause pale skin and lead to weakness or shortness of breath,
• Gastrointestinal or intestinal bleeding, bleeding from the urinary or genital tract (including blood in urine and heavy menstrual bleeding), nosebleeds, gum bleeding,
• Bleeding into the eye (including bleeding from the white part of the eye),
• Bleeding into tissues or body cavities (hematoma, bruising),
• Presence of blood in sputum (hemoptysis) during coughing,
• Bleeding from the skin or under the skin,
• Bleeding after surgery,
• Oozing of blood or fluid from a surgical wound,
• Swelling of limbs,
• Limb pain,
• Kidney function disorders (may be observed in tests performed by a doctor),
• Fever,
• Stomach pain, indigestion, nausea, or vomiting, constipation, diarrhea,
• Low blood pressure (symptoms may include dizziness or fainting upon standing),
• General weakness and fatigue, headache, dizziness,
• Rash, itching of the skin,
• Increased activity of certain liver enzymes, which may be seen in blood test results.

Uncommon adverse effects (may occur in 1 out of 100 people)

• Bleeding into the brain or inside the skull (see above signs of bleeding),
• Bleeding into a joint causing pain and swelling,
• Thrombocytopenia (low platelet count, blood cells involved in clotting),
• Allergic reactions, including allergic skin reactions,
• Blood tests may show increased levels of bilirubin, increased activity of certain pancreatic or liver enzymes, or increased platelet count,
• Fainting,
• Malaise,
• Rapid heartbeat,
• Dry mouth,
• Urticaria,
• Liver function disorders (may be observed in tests performed by a doctor).

Rare adverse effects (may occur in 1 out of 1,000 people)

• Bleeding into muscles,
• Cholestasis (bile stasis), hepatitis, including liver cell damage,
• Yellowing of the skin and eyes (jaundice),
• Localized swelling,
• Blood collection (hematoma) in the groin area as a complication of cardiac catheterization when the catheter is inserted into an artery in the leg (pseudoaneurysm).

Very rare (may occur in 1 out of 10,000 people)

• Eosinophilia, a type of white granulocytic blood cell accumulation, causing lung inflammation (eosinophilic pneumonia).

Adverse effects with unknown frequency (frequency cannot be determined from available data):

• Kidney failure following severe bleeding,
• Bleeding in the kidneys, sometimes with blood in the urine, leading to impaired kidney function (anticoagulant-related nephropathy),
• Increased pressure within the muscles of arms and legs following bleeding, which may cause pain, swelling, altered sensation, numbness, or paralysis (compartment syndrome following bleeding).

Reporting of adverse effects
If any adverse effects occur, including those not listed in this leaflet, you should consult your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store ZARIXA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after:
Expiry date and on each blister or container after: EXP. The expiry date refers to the last day of the stated month.
Do not store above 30°C.
Capsule contents:
The capsule contents remain stable in water or apple puree for up to 4 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What ZARIXA contains

• The active substance is rivaroxaban. One hard capsule contains 10 mg of rivaroxaban.
• Other ingredients are: Capsule contents: mannitol, sodium lauryl sulfate, magnesium stearate. See section 2, "ZARIXA contains sodium". Capsule shell: gelatin, titanium dioxide (E 171).

What ZARIXA looks like and contents of the pack
ZARIXA 10 mg hard gelatin capsules are size "0", with a white body and white cap, filled with white or almost white powder.
Packaged in HDPE containers with child-resistant screw caps made of PP, with tamper-evident seals, or in PVC/PVDC/Aluminum blisters, containing 10 or 30 hard capsules in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Celon Pharma S.A.
ul. Ogrodowa 2A Kiełpin
05-092 Łomianki
tel.: +48 22 75-15-933
e-mail: [email protected]

Manufacturer:
Celon Pharma S.A.
ul. Marymoncka 15
05-152 Kazuń Nowy

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Celon Pharma SA
ul. Ogrodowa 2A Kiełpin
05-092 Łomianki
tel.: +48 22 75 15 933
e-mail: [email protected]